Renal Cell CarcinomaPhase 1NCT01114230
A First in Man Study to Determine the Safety at Various Dose Levels of AGS-16M8F in Advanced Kidney Cancer
A Phase 1 study testing AGS-16M8F in people with Renal Cell Carcinoma and Pharmacokinetics of AGS-16M8F, run by Astellas Pharma Inc at 3 sites in United States.
Trial summary
The purpose of this dose escalation study is to examine the safety and pharmacokinetics (PK) of AGS-16M8F administered in subjects with advanced renal cell carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma, Pharmacokinetics of AGS-16M8F
- What is being tested?
- AGS-16M8F
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2010to Nov 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologic or cytologic diagnosis (recent or remote) of metastatic renal cell carcinoma (including papillary, clear cell, and excluding transitional cell types) that is not amenable to cure by surgery or other means.
- Non-measurable or measurable disease according to Response Criteria for Solid Tumors (RECIST Version 1.1)
- Eastern Cooperative Group (ECOG) performance status of 0-1
- Negative pregnancy test (women of childbearing potential)
- Hematologic function, as follows:
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
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- Platelet count ≥ 100 x 109/L
- Hemoglobin ≥ 9 g/dL (transfusions are allowed)
- Renal function, as follows:
- creatinine ≤ 1.5 x upper limit of normal (ULN), or calculated glomerular filtration rate (GFR) > 50 mL/min if creatinine > 1.5x ULN
- Hepatic function, as follows:
- Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.5 x ULN or ≤ 5x ULN if known liver metastases
- Total bilirubin ≤ 1.5 x ULN
- International Normalized Ratio (INR) < 1.3 (or ≤ 3.0 if on therapeutic anticoagulation)
- Women and men of childbearing potential must be advised and agree to practice effective methods of contraception during the course of the study and for four weeks after the last AGS-16M8F infusion administration
Who cannot join
- Past or present documented central nervous system (CNS) tumor or CNS metastasis
- Use of any investigational drug (including marketed drugs not approved for this indication) within 4 weeks prior to screening
- History of thromboembolic events and bleeding disorders ≤ 3 months (e.g., DVT or PE)
- Active angina or Class III or IV Congestive Heart Failure (New York Heart Association CHF Functional Classification System) or clinically significant cardiac disease within 12 months of study enrollment, including myocardial infarction, unstable angina, grade 2 or greater peripheral vascular disease, congestive heart failure, uncontrolled hypertension, or arrythmias not controlled by outpatient medication
- Major surgery (that requires general anesthesia) within 4 weeks of study enrollment
- Women who are pregnant (confirmed by positive pregnancy test) or lactating
- Known positive test for human immunodeficiency virus (HIV), hepatitis C, or hepatitis B surface antigen
- Active infection requiring treatment with systemic (intravenous or oral) anti-infectives (antibiotic, antifungal, or antiviral agent) within 72 hours of screening
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Memorial Sloan Kettering Cancer Center
New York, New York, 10021
Seattle Cancer Care Alliance
Seattle, Washington, 98109
About this study
Official title: A Phase 1, Open-label, Multi-center, Dose Escalation Study of the Safety and Pharmacokinetics of AGS-16M8F Monotherapy in Subjects With Advanced Renal Cell Carcinoma
The purpose of this dose escalation study is to examine the safety and pharmacokinetics (PK) of AGS-16M8F administered in subjects with advanced renal cell carcinoma.
- Being tested
- AGS-16M8F
- Keywords
- Advanced Renal Cell Carcinoma, Advanced Kidney Cancer, AGS-16M8F
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AGS-16M8FDrug
IV
| Study group | Role | What they receive |
|---|---|---|
| Dose Level 1 | Experimental | Not described Receives: Drug: AGS-16M8F |
| Dose Level 2 | Experimental | Not described Receives: Drug: AGS-16M8F |
| Dose Level 3 | Experimental | Not described Receives: Drug: AGS-16M8F |
| Dose Level 4 | Experimental | Not described Receives: Drug: AGS-16M8F |
| Dose Level 5 | Experimental | Not described Receives: Drug: AGS-16M8F |
| Dose Level 6 | Experimental | Not described Receives: Drug: AGS-16M8F |
| Dose Level 7 | Experimental | Not described Receives: Drug: AGS-16M8F |
| Dose Level 8 | Experimental | Not described Receives: Drug: AGS-16M8F |
| Dose Level 9 | Experimental | Not described Receives: Drug: AGS-16M8F |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessed by recording adverse events, vital signs and laboratory assessments
Measured: For 12 weeks during treatment period and up to 4 weeks follow up
Pharmacokinetic variables assessment through analysis of blood samples
Measured: Up to day 15 for cycle 1 and cycle 4 and pre-dose for cycles 2 and 3; every 3 weeks during the second 12 weeks of treatment; and if subject continues on study drug, every 12 weeks thereafter
Secondary outcomes (2)
Incidence of anti-AGS-16M8F antibody formation
Measured: Baseline; up to day 64 during the first 12 weeks; and if subject continues on study drug, every 3 weeks during the second 12 weeks of treatment and every 12 weeks thereafter
Incidence of Tumor Response (complete or partial response)
Measured: Baseline and every 12 weeks while on study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2010 (estimated)
- Study startAug 2010
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Agensys, Inc.
- Responsible party
- Sponsor
- Investigators
- Chief Medical Officer, Study director, Agensys, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01114230
- Sponsor's protocol ID
- 2009002
- Status last verified
- Dec 2012
- First submitted
- 29 Apr 2010
- Last updated
- 12 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Multi-center, Dose Escalation Study of the Safety and Pharmacokinetics of AGS-16M8F Monotherapy in Subjects With Advanced Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT01114230
- Acronym / sponsor ID
- 2009002
- Keywords
- Advanced Renal Cell Carcinoma, Advanced Kidney Cancer, AGS-16M8F
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- Agensys, Inc.
- Study start
- Aug 2010
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 3 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this dose escalation study is to examine the safety and pharmacokinetics (PK) of AGS-16M8F administered in subjects with advanced renal cell carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Dose Level 1 | Experimental | Drug: AGS-16M8F |
| Dose Level 2 | Experimental | Drug: AGS-16M8F |
| Dose Level 3 | Experimental | Drug: AGS-16M8F |
| Dose Level 4 | Experimental | Drug: AGS-16M8F |
| Dose Level 5 | Experimental | Drug: AGS-16M8F |
| Dose Level 6 | Experimental | Drug: AGS-16M8F |
| Dose Level 7 | Experimental | Drug: AGS-16M8F |
| Dose Level 8 | Experimental | Drug: AGS-16M8F |
| Dose Level 9 | Experimental | Drug: AGS-16M8F |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Histologic or cytologic diagnosis (recent or remote) of metastatic renal cell carcinoma (including papillary, clear cell, and excluding transitional cell types) that is not amenable to cure by surgery or other means.
- Non-measurable or measurable disease according to Response Criteria for Solid Tumors (RECIST Version 1.1)
- Eastern Cooperative Group (ECOG) performance status of 0-1
- Negative pregnancy test (women of childbearing potential)
- Hematologic function, as follows:
Key exclusion criteria (8 listed)
- Past or present documented central nervous system (CNS) tumor or CNS metastasis
- Use of any investigational drug (including marketed drugs not approved for this indication) within 4 weeks prior to screening
- History of thromboembolic events and bleeding disorders ≤ 3 months (e.g., DVT or PE)
- Active angina or Class III or IV Congestive Heart Failure (New York Heart Association CHF Functional Classification System) or clinically significant cardiac disease within 12 months of study enrollment, including myocardial infarction, unstable angina, grade 2 or greater peripheral vascular disease, congestive heart failure, uncontrolled hypertension, or arrythmias not controlled by outpatient medication
- Major surgery (that requires general anesthesia) within 4 weeks of study enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AGS-16M8FIV | Drug | Dose Level 1, Dose Level 2, Dose Level 3, Dose Level 4, Dose Level 5, Dose Level 6, Dose Level 7, Dose Level 8, Dose Level 9 |
Primary outcome
Safety assessed by recording adverse events, vital signs and laboratory assessments
Time frame: For 12 weeks during treatment period and up to 4 weeks follow up
Pharmacokinetic variables assessment through analysis of blood samples
Time frame: Up to day 15 for cycle 1 and cycle 4 and pre-dose for cycles 2 and 3; every 3 weeks during the second 12 weeks of treatment; and if subject continues on study drug, every 12 weeks thereafter
2 secondary outcomes
Incidence of anti-AGS-16M8F antibody formation
Time frame: Baseline; up to day 64 during the first 12 weeks; and if subject continues on study drug, every 3 weeks during the second 12 weeks of treatment and every 12 weeks thereafter
Incidence of Tumor Response (complete or partial response)
Time frame: Baseline and every 12 weeks while on study drug
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chief Medical Officer study director
Agensys, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AGS-16M8F in people with Renal Cell Carcinoma and Pharmacokinetics of AGS-16M8F, run by Astellas Pharma Inc at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety assessed by recording adverse events, vital signs and laboratory assessments (time frame: For 12 weeks during treatment period and up to 4 weeks follow up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2012; AzTrials last refreshed its copy on 1 Nov 2026.